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Author: Meijuan Li
Publisher: Chapman & Hall/CRC
ISBN: 9781138033634
Category :
Languages : en
Pages : 250
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Book Description
A key component of personalized medicine is companion diagnostics that measure biomarkers e.g. protein expression, gene amplification or specific mutations. This will be the first book that covers (1) companion diagnostic device measurement performance, (2) companion diagnostic device clinical performance, (3) companion diagnostic device bridging study, (4) follow-on companion diagnostic device, and (5) the impact of companion diagnostic device measurement performance on clinical validation of personalized medicine.
Author: Meijuan Li
Publisher: Chapman & Hall/CRC
ISBN: 9781138033634
Category :
Languages : en
Pages : 250
Get Book Here
Book Description
A key component of personalized medicine is companion diagnostics that measure biomarkers e.g. protein expression, gene amplification or specific mutations. This will be the first book that covers (1) companion diagnostic device measurement performance, (2) companion diagnostic device clinical performance, (3) companion diagnostic device bridging study, (4) follow-on companion diagnostic device, and (5) the impact of companion diagnostic device measurement performance on clinical validation of personalized medicine.
Author: Il-Jin Kim
Publisher: CRC Press
ISBN: 1000007219
Category : Computers
Languages : en
Pages : 256
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Book Description
There is a new trend in anti-cancer therapeutics development: a targeted therapy and precision medicine that targets a subgroup of patients with specific biomarkers. An in vitro diagnostic (IVD) assay is required to identify a subgroup of cancer patients who would benefit from the targeted therapy, or not likely benefit, or have a high risk of side effects from the specific drug treatment. This IVD or medical device is called a companion diagnostic (CDx) assay. It is key to have a robust CDx assay or device for the success of targeted therapy and precision medicine. This book covers the technical, historical, clinical, and regulatory aspects of CDx in precision medicine. Clearly, more and more newly developed oncology drugs will require accompanying CDx assays, and this book, with chapters contributed by renowned oncologists, provides a comprehensive foundation for the knowledge and application of CDx for precision medicine.
Author: Jan Trøst Jørgensen
Publisher: Academic Press
ISBN: 0128135409
Category : Medical
Languages : en
Pages : 509
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Book Description
Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. - Covers all aspects, from biomarker discovery, to development and regulatory approval - Explains the "how to" aspects of companion diagnostics - Incorporates information on the entire process, allowing for easier and deeper understanding of the topic
Author: Abdel Halim
Publisher: Academic Press
ISBN: 0128161221
Category : Medical
Languages : en
Pages : 294
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Book Description
The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management. Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations
Author: Haibo Song
Publisher: Springer Nature
ISBN: 9811623163
Category : Medical
Languages : en
Pages : 287
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Book Description
This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of eight parts, including the overview on the IVD industry in China in 2019, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, molecular diagnosis, blood and body fluid diagnosis, microbial detection, point-of-care testing, laboratory assembly line, etc. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.
Author: Ernst R. Berndt
Publisher: University of Chicago Press
ISBN: 022661123X
Category : Business & Economics
Languages : en
Pages : 361
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Book Description
Personalized and precision medicine (PPM)—the targeting of therapies according to an individual’s genetic, environmental, or lifestyle characteristics—is becoming an increasingly important approach in health care treatment and prevention. The advancement of PPM is a challenge in traditional clinical, reimbursement, and regulatory landscapes because it is costly to develop and introduces a wide range of scientific, clinical, ethical, and socioeconomic issues. PPM raises a multitude of economic issues, including how information on accurate diagnosis and treatment success will be disseminated and who will bear the cost; changes to physician training to incorporate genetics, probability and statistics, and economic considerations; questions about whether the benefits of PPM will be confined to developed countries or will diffuse to emerging economies with less developed health care systems; the effects of patient heterogeneity on cost-effectiveness analysis; and opportunities for PPM’s growth beyond treatment of acute illness, such as prevention and reversal of chronic conditions. This volume explores the intersection of the scientific, clinical, and economic factors affecting the development of PPM, including its effects on the drug pipeline, on reimbursement of PPM diagnostics and treatments, and on funding of the requisite underlying research; and it examines recent empirical applications of PPM.
Author: Michael Mahler
Publisher: Academic Press
ISBN: 032385432X
Category : Science
Languages : en
Pages : 302
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Book Description
Precision Medicine and Artificial Intelligence: The Perfect Fit for Autoimmunity covers background on artificial intelligence (AI), its link to precision medicine (PM), and examples of AI in healthcare, especially autoimmunity. The book highlights future perspectives and potential directions as AI has gained significant attention during the past decade. Autoimmune diseases are complex and heterogeneous conditions, but exciting new developments and implementation tactics surrounding automated systems have enabled the generation of large datasets, making autoimmunity an ideal target for AI and precision medicine. More and more diagnostic products utilize AI, which is also starting to be supported by regulatory agencies such as the Food and Drug Administration (FDA). Knowledge generation by leveraging large datasets including demographic, environmental, clinical and biomarker data has the potential to not only impact the diagnosis of patients, but also disease prediction, prognosis and treatment options. - Allows the readers to gain an overview on precision medicine for autoimmune diseases leveraging AI solutions - Provides background, milestone and examples of precision medicine - Outlines the paradigm shift towards precision medicine driven by value-based systems - Discusses future applications of precision medicine research using AI - Other aspects covered in the book include regulatory insights, data analytics and visualization, types of biomarkers as well as the role of the patient in precision medicine
Author: Sara Hurvitz
Publisher: Elsevier Health Sciences
ISBN: 0323581234
Category : Medical
Languages : en
Pages : 264
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Book Description
Get a quick, expert overview of clinically-focused topics and guidelines that are relevant to testing for HER2, which contributes to approximately 25% of breast cancers today. This concise resource by Drs. Sara Hurvitz, and Kelly McCann consolidates today’s available information on this growing topic into one convenient resource, making it an ideal, easy-to-digest reference for practicing and trainee oncologists.
Author: Joel Faintuch
Publisher: Academic Press
ISBN: 0128191791
Category : Science
Languages : en
Pages : 640
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Book Description
Precision Medicine for Investigators, Practitioners and Providers addresses the needs of investigators by covering the topic as an umbrella concept, from new drug trials to wearable diagnostic devices, and from pediatrics to psychiatry in a manner that is up-to-date and authoritative. Sections include broad coverage of concerning disease groups and ancillary information about techniques, resources and consequences. Moreover, each chapter follows a structured blueprint, so that multiple, essential items are not overlooked. Instead of simply concentrating on a limited number of extensive and pedantic coverages, scholarly diagrams are also included. Provides a three-pronged approach to precision medicine that is focused on investigators, practitioners and healthcare providers Covers disease groups and ancillary information about techniques, resources and consequences Follows a structured blueprint, ensuring essential chapters items are not overlooked
Author: Mohamad Bydon
Publisher: Elsevier
ISBN: 0443139644
Category : Science
Languages : en
Pages : 272
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Book Description
The New Era of Precision Medicine: What it Means for Patients and the Future of Healthcare highlights aspects of precision medicine in different specialties and offers an understanding of how a biological background integrates into clinical guidelines, the therapeutic efficacy of interventions and disease prevention. The book explains how precision healthcare differs among countries, as well as how there is a collaboration among many labs to share resources and knowledge to advance the field across the globe. The book also discusses the cultural differences and cultural sensitivity that may be involved in the precision medicine approach. Finally, with regard to safety and quality outcomes, the book presents a range of current and possible future concerns related to those outcomes. Precision medicine is the new standard of quality healthcare delivery. It aims to optimize patient safety and clinical outcomes, enhance the efficacy of therapeutic interventions, and facilitate disease prevention, offering a way to customize patient care, decision-making, and clinical practice. - Highlights the characteristics of precision medicine in different areas - Offers an understanding of how a biological background integrates into clinical guidelines, the therapeutic efficacy of interventions, and disease prevention - Emphasizes how medicine has transformed from a "one-size-fits-all approach to personalized medicine influenced by individual characteristics - Introduces complex topics delivered in terms that target a broad range of audiences
